China's First BCMA-Targeted CAR-T Therapy Equecabtagene Autoleucel Approved for Relapsed/Refractory Multiple Myeloma
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Written by丨WYX
June 30, 2023China's National Medical Products Administration (NMPA) has granted conditional approval for the marketing of Idecabtagene Vicleucel Injection through the priority review and approval process, for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM)., progressed after at least 3 prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).
Source: https://www.nmpa.gov.cn/
Previously, Iaso Bio's Equecabtagene Autoleucel Injection was granted "Breakthrough Therapy Designation (BTD)" by the NMPA and "Orphan Drug Designation (ODD)" by the FDA. In June 2022, the new drug application for Equecabtagene Autoleucel Injection for the treatment of R/R MM was officially accepted by the NMPA, and in the same year, it was approved for registration clinical trials by the U.S. FDA. In February 2023, Equecabtagene Autoleucel Injection received both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track (FT) designation from the FDA.
Idecabtagene Vicleucel Injection is an autologous immune cell injectable agent jointly developed by IASO Bio and Innovent Bio. It is prepared by using a lentiviral vector to integrate the chimeric antigen receptor (CAR) gene targeting B-cell maturation antigen (BCMA) into the patient's autologous peripheral blood CD3-positive T cells.After being reinfused into the patient's body, it kills tumor cells by recognizing the BCMA target on the surface of multiple myeloma cells.
The marketing application of Ixazomib Injection is based on the results of a Phase 1/2 registrational clinical study. In June this year, the safety and efficacy data of the study were updated at the American Society of Clinical Oncology (ASCO) Annual Meeting. As of September 9, 2022, the study had enrolled a total of 103 subjects who received the infusion of Ixazomib Injection, with an infusion dose of 1.0×10.6CAR-T/kg, with a median follow-up time of 13.8 (0.4, 27.2) months, and a median number of prior treatment lines of 4 (3~23) lines.
The overall response rate (ORR) reached 96.0% (97/101), with 91.1% (92/101) of subjects achieving very good partial response or better (≥VGPR), and the stringent complete response/complete response rate (sCR/CR) was 74.3% (75/101);
The median time to response was 16 days, with neither the median duration of response (DOR) nor the median progression-free survival (PFS) reached; the 12-month PFS rate was 78.8% (95% CI: 68.6–85.97).
95.0% (96/101) of subjects achieved minimal residual disease (MRD) negativity, with all sCR/CR subjects achieving MRD negativity. 82.4% of subjects maintained MRD negativity for over 12 months, and the median duration of MRD negativity has not yet been reached.
In the study, Ixcell injection also demonstrated good efficacy in MM subjects who had previously received CAR-T treatment. Among 12 MM subjects who had previously received CAR-T treatment, 9 achieved ORR, 5 achieved sCR, with 4 maintaining sCR for over 18 months.
Among 103 subjects, 93.2% (96/103) experienced cytokine release syndrome (CRS), the vast majority being grade 1-2, with only one subject experiencing grade 3 or higher CRS. Only 2.5% (2/79) of subjects developed immune effector cell-associated neurotoxicity syndrome (ICANS), including one case each of grade 1 and grade 2. All subjects' CRS and ICANS were resolved. The most common drug-related adverse event was hematological toxicity. The safety of the Icaritin Injection is overall controllable.
MM is a malignant disease characterized by the abnormal proliferation of clonal plasma cells. It is the second most common hematologic malignancy in many countries, primarily affecting the elderly, and currently remains incurable. While most patients achieve disease stabilization for 3-5 years following first-line treatment, the majority inevitably progress to a relapsed/refractory stage. Therefore, there remains an unmet need for patients with R/R MM.
The marketing of Ixazomifene Injection brings new treatment options and survival hope to MM patients in China. It is expected that Ixazomifene Injection will be applied in clinical practice as soon as possible to benefit MM patients!
Source: Hematology Channel of Medicine Circle
Editor: Zhang Rongxin
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